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Cassava (SAVA) Posts Top-Line Data from AD Study on Simufilam

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Cassava Sciences, Inc. SAVA announced top-line data from an interim analysis of the ongoing study evaluating its drug candidate, simufilam, for treating patients with mild-to-moderate Alzheimer’s disease (“AD”).

Data from the study showed that the first 50 subjects who completed one year of open-label treatment with simufilam saw their cognition scores improve at an average of 3.2 points on Alzheimer’s Disease Assessment Scale–Cognitive Subscale (ADAS-Cog) from the baseline. The study is being funded by the National Institutes of Health.

68% of study subjects showed improvement on ADAS-Cog and an additional 20% of the subjects showed decline of less than five points on ADAS-Cog at 12 months of treatment.

Overall, treatment with simufilam was generally well-tolerated, with no serious adverse side effect observed through the 12-month interim analysis.

Shares of Cassava have skyrocketed 667% so far this year against the industry’s decrease of 12.5%.

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In August 2021, Cassava reached an agreement with the FDA on Special Protocol Assessments (“SPA”) for its phase III studies of simufilam for the treatment of AD. The SPAs underscore the company’s alignment with the FDA on key scientific, clinical and regulatory requirements of the phase III program of simufilam in AD. The company plans to initiate the studies in the fourth quarter of 2021.

Simufilam is a proprietary, small-molecule (oral) drug that restores the normal shape and function of altered filamin A, a scaffolding protein, in the brain.

Quite a few companies are striving hard to get their AD drugs approved. Eli Lilly LLY is developing donanemab, an investigational antibody therapy, for AD. Small biotech Annovis Bio, Inc. ANVS is also developing its pipeline candidate in mid-stage study for treating AD.

The FDA approval of Biogen’s BIIB AD drug, Aduhelm (aducanumab), has put the spotlight on this promising yet challenging space. In June 2021, Biogen and its partner Eisai won the FDA approval for Aduhelm as the first and only AD treatment, after a few setbacks.

Zacks Rank

Cassava currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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Biogen Inc. (BIIB) : Free Stock Analysis Report

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